ProspectivE phase 0 pilot study, assessing potential prognostic and theranostic interest of 68Ga-PentiXafor PET-CT In metastatic triple neGative brEast caNCer patiEnts (EXIGENCE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut De Cancerologie De L Ouest

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Dec 2025 → ongoing

Decision date (initial)

2025-03-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

PENTIXAPAHRM · SIRIC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To assess the concordance for tumor lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at patient inclusion.

Secondary objectives 8

1. a) To assess the concordance for tumor lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT.
2. b) To assess the concordance for tumor lesion detection with [68Ga]Ga-PentixaFor PET/CT and conventional imaging CT scan based on a lesion-by-lesion basis analysis performed at patient inclusion.
3. c) To assess the concordance for tumor lesion detection with [68Ga]Ga-PentixaFor PET/CT and conventional imaging: CT scan based on a lesion-by-lesion basis analysis performed at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT.
4. d) To determine the percentage of total tumor burden (whole body) detected on [68Ga]Ga-PentixaFor PET/CT compared to that defined on [18F]FDG PET/CT (considered as reference).
5. e) To assess the correlation between the standard uptake values (SUV) of [68Ga]Ga-PentixaFor and CXCR4 expression by IHC assessment on primitive and/or metastatic tumor samples at screening and at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT if a biopsy is performed .
6. f) To assess the safety and tolerance of [68Ga]Ga-PentixaFor.
7. Exploratory ) To assess the prognostic value of serum FLT3-Ligand in relapsing Triple Negative Breast Cancer patients.
8. g) Description of the evolution of [68Ga]Ga-PentixaFor PET-CT data obtained at patient inclusion and at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT at the patient level.

Conditions and MedDRA coding

triple-negative breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 1) Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
2. 2) Female or male, Age ≥ 18 years at time of study entry
3. 3) Primitive triple negative breast cancer proven histologically, defined according to the following criteria:  Estrogen receptors <10%.  And progesterone receptors <10%.  And HER2 not amplified or not overexpressed
4. Metastatic status documented by [18F]FDG PET/CT ± conventional imaging with at least one evaluable metastasis in [18F]FDG PET/CT according to PERCIST
5. 5) ECOG performance status < 2.
6. 6) Negative serum/urine pregnancy test prior to [68Ga]Ga-PentixaFor administration.
7. 7) Consent to use a contraception method for at least 3 months after each administration of [68Ga]Ga-PentixaFor.
8. 8) Adequate Organ function confirmed by laboratory tests results allowing for safe administration of [68Ga]Ga-PTF
9. 9) Life expectancy at least 3 months.
10. 10) Patient has valid health insurance
11. 11) Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Exclusion criteria 12

1. 1) History of another primary malignancy within the last 3 years except for basal cell carcinoma.
2. 2) Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first [68Ga]Ga-PTF administration
3. 3) Impossibility to hold lying motionless at least 1 hour, or known claustrophobia
4. 4) Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator
5. 5) Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
6. 6) Pregnant, likely to be pregnant or breastfeeding woman
7. 7) Unstable diabetes with blood glucose > 2 g/L
8. 8) Renal insufficiency with GFR ≤ 45 mL/min/ 1.73 m².
9. 9) Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PentixaFor and/or [18F]FDG product
10. 10) Body weight of less than 48 kg
11. 11) Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian
12. 12) Disorder precluding understanding of trial information or informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Concordance study of metastatic uptake seen in [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan per "lesion" by comparing for each lesion the [18F]FDG PET scan and [68Ga]Ga-PentixaFor PET/CT scan by assessing a ratio "Number of positive or negative [68Ga]Ga-PentixaFor lesions / Number of positive or negative FDG lesions” performed at patient inclusion.

Secondary endpoints 8

1. a) Concordance study of metastatic uptake seen in [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan per "lesion" by comparing for each lesion the [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan by assessing a ratio "Number of positive or negative [68Ga]Ga-PentixaFor lesions / Number of positive or negative FDG lesions” performed at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT. .
2. b) Conventional imaging (CT scan), and [68Ga]Ga-PentixaFor PET/CT will be analysed for each lesion, obtaining a ratio of number of [68Ga]Ga-PentixaFor(+) lesions / number of CT scan lesions" at patient inclusion.
3. c) Conventional imaging: CT scan, and [68Ga]Ga-PentixaFor PET/CT will be analysed for each lesion, obtaining a ratio of number of [68Ga]Ga-PentixaFor(+) lesions / number of CT scan lesions" at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT
4. d) Percentage of [68Ga]Ga-PentixaFor(+) metastatic tumor burden compared to total metastatic tumor burden by [18F]FDG PET/CT .
5. e) Assess the correlation between the standard uptake values (SUV) of [68Ga]Ga-PentixaFor and IHC CXCR4 expression, by comparing the [68Ga]Ga-PentixaFor semi-quantitative data with the CXCR4 expression results of biopsied metastases at screening and at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT if biopsy is performed.
6. f) The tolerance of [68Ga]Ga-PentixaFor will be checked by measuring and monitoring vital signs for 60 minutes after [68Ga]Ga-PentixaFor administration. The patient will be informed that in the event of abnormal physical signs, occurring within 48 hours after [68Ga]Ga-PentixaFor administration, he (she) must inform the investigator for registration. The CTC-NCI Common Toxicity Criteria, version 5.0 reference will be used.
7. g) Description of [68Ga]Ga-PentixaFor PET-CT data between patient inclusion time and imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT at the patient level will focus on the evolution of SUV.
8. Exploratory )Plasma FLT3-Ligand dosage will be assessed at screening and at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut De Cancerologie De L Ouest

Sponsor organisation

Institut De Cancerologie De L Ouest

Address

Boulevard Jacques Monod

City

Saint-Herblain Cedex

Postcode

44805

Country

France

Scientific contact point

Organisation

Institut De Cancerologie De L Ouest

Contact name

Dr Caroline ROUSSEAU

Public contact point

Organisation

Institut De Cancerologie De L Ouest

Contact name

Dr Caroline ROUSSEAU

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications